follitropin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4928	146479-72-3

Description:

Molecule	Description
Synonyms: follitropin delta follitropin alfa follitropin beta follitropin alfa/beta follicle-stimulating hormone urofollitropin follitropin human follicle stimulating hormone FSH	A protein extract of human menopausal urine in which LUTEINIZING HORMONE has been partially or completely removed. Urofollitropin represents FOLLICLE STIMULATING HORMONE from the urine. Molecular weight: 22668.79 Formula: C975H1493N267O305S26 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 5077.47 ALOGS: ROTB: None

Molecule

Description

Synonyms:

follitropin delta
follitropin alfa
follitropin beta
follitropin alfa/beta
follicle-stimulating hormone
urofollitropin
follitropin
human follicle stimulating hormone
FSH

A protein extract of human menopausal urine in which LUTEINIZING HORMONE has been partially or completely removed. Urofollitropin represents FOLLICLE STIMULATING HORMONE from the urine.

Molecular weight: 22668.79
Formula: C975H1493N267O305S26
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 5077.47
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
75	U	P
75	U	P
75	U	P
12	mcg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Sept. 18, 1986	FDA	SERONO
Jan. 23, 2006	PMDA	SERONO JAPAN

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Ovarian hyperstimulation syndrome	3851.49	48.20	567	3372	2677	50598508
Ascites	632.04	48.20	193	3746	35668	50565517
No adverse event	232.11	48.20	90	3849	33488	50567697
Maternal exposure before pregnancy	169.04	48.20	46	3893	5551	50595634
Ovarian enlargement	153.09	48.20	27	3912	415	50600770
Haemoperitoneum	151.51	48.20	36	3903	2519	50598666
Inappropriate schedule of product administration	149.99	48.20	84	3855	71747	50529438
Product quality issue	145.68	48.20	63	3876	30795	50570390
Adnexal torsion	140.46	48.20	23	3916	220	50600965
Abdominal distension	127.51	48.20	76	3863	72827	50528358
Ovarian haemorrhage	107.65	48.20	19	3920	293	50600892
Pelvic fluid collection	101.80	48.20	21	3918	762	50600423
Product packaging quantity issue	100.62	48.20	22	3917	1058	50600127
Abortion spontaneous	98.50	48.20	53	3886	41719	50559466
Poor quality device used	93.89	48.20	23	3916	1828	50599357
Progesterone increased	92.00	48.20	13	3926	39	50601146
Pleural effusion	70.47	48.20	55	3884	81399	50519786
Ovarian cyst ruptured	63.54	48.20	15	3924	1018	50600167
Incorrect dose administered	60.81	48.20	41	3898	48373	50552812
Circumstance or information capable of leading to medication error	59.40	48.20	18	3921	3170	50598015
Abortion	57.36	48.20	16	3923	2108	50599077
Abortion missed	57.13	48.20	15	3924	1573	50599612
Ectopic pregnancy	55.91	48.20	16	3923	2311	50598874
Multiple pregnancy	51.85	48.20	8	3931	50	50601135
Premature ovulation	51.22	48.20	7	3932	15	50601170
Oestradiol decreased	48.60	48.20	7	3932	25	50601160

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Ovarian hyperstimulation syndrome	3846.89	52.48	521	2444	2324	64493443
Ascites	595.57	52.48	185	2780	61816	64433951
Ovarian enlargement	175.79	52.48	27	2938	296	64495471
Adnexal torsion	149.81	52.48	22	2943	173	64495594
Haemoperitoneum	139.34	52.48	33	2932	3882	64491885
Pelvic fluid collection	116.83	52.48	21	2944	627	64495140
Maternal exposure before pregnancy	111.73	52.48	27	2938	3456	64492311
Ovarian haemorrhage	111.63	52.48	18	2947	275	64495492
Progesterone increased	99.10	52.48	13	2952	38	64495729
Abdominal distension	93.72	52.48	57	2908	95937	64399830
Ovarian cyst ruptured	68.23	52.48	14	2951	847	64494920
Pleural effusion	68.08	52.48	52	2913	126507	64369260
Abortion missed	58.40	52.48	13	2952	1159	64494608
Product quality issue	57.98	52.48	28	2937	29771	64465996
Premature ovulation	55.93	52.48	7	2958	12	64495755

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G03GA04	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM GONADOTROPINS AND OTHER OVULATION STIMULANTS Gonadotropins
ATC	G03GA05	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM GONADOTROPINS AND OTHER OVULATION STIMULANTS Gonadotropins
ATC	G03GA06	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM GONADOTROPINS AND OTHER OVULATION STIMULANTS Gonadotropins
ATC	G03GA10	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM GONADOTROPINS AND OTHER OVULATION STIMULANTS Gonadotropins
FDA CS	M0009540	Gonadotropins
MeSH PA	D006728	Hormones
FDA EPC	N0000175838	Gonadotropin

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Ovulation induction	indication	61285001

🐶 Veterinary Drug Use

Species	Use	Relation
Cattle	Induction or superovulation	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Super-Ov	Therio Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Follicle-stimulating hormone receptor	GPCR	P23945	FSHR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D06269	KEGG_DRUG
4019254	VUID
N0000147458	NUI
4019253	VANDF
4019254	VANDF
4021069	VANDF
4021070	VANDF
4024094	VANDF
CHEBI:81569	CHEBI
CHEMBL4297955	ChEMBL_ID
CHEMBL1201692	ChEMBL_ID
CHEMBL2108427	ChEMBL_ID
C000620228	MESH_SUPPLEMENTAL_RECORD_UI
C571801	MESH_SUPPLEMENTAL_RECORD_UI
C571802	MESH_SUPPLEMENTAL_RECORD_UI
1157	IUPHAR_LIGAND_ID
9503	INN_ID
DB00066	DRUGBANK_ID
076WHW89TW	UNII
62819	PUBCHEM_CID
DB00094	DRUGBANK_ID
134404	RXNORM
4760	MMSL
5657	MMSL
7863	MMSL
7864	MMSL
d00570	MMSL
d04043	MMSL
002102	NDDF
006654	NDDF
006941	NDDF
006978	NDDF
103028007	SNOMEDCT_US
109042006	SNOMEDCT_US
109044007	SNOMEDCT_US
126185008	SNOMEDCT_US
25217009	SNOMEDCT_US
325781003	SNOMEDCT_US
395862009	SNOMEDCT_US
395920003	SNOMEDCT_US
725743001	SNOMEDCT_US
763577005	SNOMEDCT_US
768662008	SNOMEDCT_US
D005640	MESH_DESCRIPTOR_UI
D050477	MESH_DESCRIPTOR_UI
C0733758	UMLSCUI
CHEMBL1201520	ChEMBL_ID
9732	INN_ID
1919	INN_ID
7505	INN_ID
4798	INN_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Follistim AQ	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0313	INJECTION, SOLUTION	350 [iU]	SUBCUTANEOUS	BLA	28 sections
Follistim AQ	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0316	INJECTION, SOLUTION	650 [iU]	SUBCUTANEOUS	BLA	28 sections
Follistim AQ	HUMAN PRESCRIPTION DRUG LABEL	1	0052-0326	INJECTION, SOLUTION	975 [iU]	SUBCUTANEOUS	BLA	28 sections
Gonal-f RFF Redi-ject	HUMAN PRESCRIPTION DRUG LABEL	1	44087-1115	INJECTION, SOLUTION	300 [iU]	SUBCUTANEOUS	BLA	28 sections
Gonal-f RFF Redi-ject	HUMAN PRESCRIPTION DRUG LABEL	1	44087-1116	INJECTION, SOLUTION	450 [iU]	SUBCUTANEOUS	BLA	28 sections
Gonal-f RFF Redi-ject	HUMAN PRESCRIPTION DRUG LABEL	1	44087-1117	INJECTION, SOLUTION	900 [iU]	SUBCUTANEOUS	BLA	28 sections